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Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START) — START  

Respiratory Distress Syndrome, Adult Clinical Trial

Official title:
Prospective, Randomized, Multi-center Phase 2 Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

Clinical Trial Summary

This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS).

Clinical Trial Description

We carried out a randomized, double-blind placebo-controlled trial of allogeneic bone marrow derived human mesenchymal stromal cells for treatment of moderate to severe ARDS in 60 patients, 40 MSC and 20 placebo, in a 2:1 randomization. This trial is the extension of the Phase 1 pilot trial (NCT01775774). Patients were followed daily for adverse events through day 28, death or hospital discharge, whichever occurs first. Vital status was collected at 6 and 12 months after study enrollment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02097641
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase Phase 2
Start date March 15, 2014
Completion date February 9, 2018
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